Novartis breached Clauses 2, 5.1 and 12.1 after outdated Entresto prescribing information appeared in downloadable HCP portal documents (AUTH/3725/1/23)

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Key facts

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Case	AUTH/3725/1/23
Parties	Complainant v Novartis Pharmaceuticals UK
Product	Entresto (sacubitril/valsartan)
Issue	Outdated prescribing information embedded in downloadable documents on an HCP portal
Documents	Document A: “The Affinity Care Heart Failure Pathway”; Document B: “JACC Treatment Algorithm for Guideline-Directed Medical Therapy Including Novel Therapies”
PI dates noted	Document A: May 2021; Document B: June 2020; Webpage PI: October 2022
Complaint received	10 January 2023
Case completed	18 March 2024
Applicable Code	2021
Breach clauses	Clause 2; Clause 5.1 (x3); Clause 12.1 (x2)
No breach clauses	Clause 8.5 (x2)
Sanctions	Undertaking received; Advertisement
Appeal	No appeal

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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An anonymous health professional complained about Entresto (sacubitril/valsartan) prescribing information (PI) on Novartis’ UK HCP portal.
Two downloadable documents contained older PI than the PI shown on the webpage:
- Document A: “The Affinity Care Heart Failure Pathway” included PI dated May 2021.
- Document B: “JACC Treatment Algorithm for Guideline-Directed Medical Therapy Including Novel Therapies” included PI dated June 2020 (and Novartis also provided a May 2021 version in its submission, but the Panel said it should have been updated to Oct 2022 regardless).
- The webpage PI was dated October 2022 (GB and NI split).
Novartis argued the most up-to-date PI was accessible via a link at the top of the webpage, but the Panel noted Clause 12.1 requires PI to form part of the material (not be separate), especially for downloadable items.
The Panel noted differences between Oct 2022 and June 2020 PI included missing safety-related updates (e.g., “splitting or crushing of tablets is not recommended”, psychiatric disorder warnings/effects, and updated lithium interaction wording including a statement about diuretics increasing lithium toxicity risk).
Novartis said it identified the issue on 19 January 2023 and contacted its agency to remove affected materials; the PMCPA notified Novartis of the complaint on 20 January 2023. The Panel reviewed emails and considered there was a lack of urgency until the PMCPA complaint was received.

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Breach of Clause 2 (bringing discredit upon, and reducing confidence in, the pharmaceutical industry).
Breach of Clause 5.1 (x3) (failing to maintain high standards).
Breach of Clause 12.1 (x2) (failing to include up-to-date prescribing information).
No breach of Clause 8.5 (x2) (recertification interval of no more than two years) on the narrow ground that two years had not elapsed since certification.

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